Quality Assurance Officer

RxCelerate

Closing Date: 14/06/2022

Quality Assurance Manager will have responsibility for maintaining high standards of cGxP quality and
ensuring compliance requirements are met. An additional responsibility of this position will be the
role of the archivist for RxCelerate’s cGxP activities. The ability to prioritise work and deliver within
a dynamic and demanding scientific environment to meet challenging deadlines is essential.
Main Responsibilities
• Act as the primary source for quality assurance in the company
• Define the audit schedule; co-ordinate and carry out audits as required
• Review SOPs and controlled documents to ensure compliance
• Act as a point of contact for compliance queries
• Maintain oversight of the CAPA process
• Plan document review processes
• Train staff in cGxP principles and audit readiness
• Responsible for the day-to-day management of the site Archive activities
• Take responsibility for archiving all GxP-related material in an efficient and timely manner and
maintaining physical and electronic archive records
• Ensure documents retained within the Archives are securely stored and easily retrievable in
accordance with site and global archiving procedures
• Oversee the implementation of an electronic archive
• Manage the RxCelerate biobank and its associated databases
Skills/Requirements
• A degree in a life sciences discipline and ideally at least 3 years’ experience in a corporate
setting
• RQA certification is desirable
• An understanding of cGxP regulatory requirements is essential, particularly cGLP and cGCP
• Experience of interfacing with regulatory bodies, including the MHRA
• An understanding of the HTA is desirable
• Experience in auditing GxP studies, processes and facilities
• Experience of documentation control
• Archiving experience is desirable
• Experience of training staff
• Strong verbal and written communication skills, organisational skills; excellent attention to
detail
This is a full-time role, though applicants seeking employment on a part-time basis (3.5–4 days per
week) are also encouraged to apply. RxCelerate offers a competitive salary with an annual bonus
scheme and company benefit package.
When applying for this role, please include a cover letter outlining how you meet the competencies
described above. Interested applicants should send their cover letter and curriculum vitae in PDF
format to careers@rxcelerate.com. Informal enquiries can also be directed to this email address. Only
applicants based in the UK and EU need apply, as this role does not qualify for international
sponsorship.